Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
42 participants
INTERVENTIONAL
2011-03-31
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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KW-2246
KW-2246
Rescue medication at an optimal dose, which is determined by dose titration
Placebo
Placebo
Interventions
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KW-2246
Rescue medication at an optimal dose, which is determined by dose titration
Placebo
Eligibility Criteria
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Inclusion Criteria
* Have been treated with opioid analgesic on a fixed-schedule at a stable daily dose
* Receiving at least 1 but not more than 4 doses of rescue medication per day in average and whose pain is controlled
* ECOG PS =\< 3
Exclusion Criteria
* Severe respiratory dysfunction
* Asthma
* Severe bradyarrhythmia
* Severe hepatic function disorder
* Severe renal function disorder
* Severe psychoneurotic disorder
* Susceptibility to respiratory depression due to such conditions as increased intracranial pressure, head injury or brain tumor
20 Years
ALL
No
Sponsors
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Kyowa Kirin Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Tokyo, , Japan
Countries
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References
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Shimoyama N, Gomyo I, Katakami N, Okada M, Yukitoshi N, Ohta E, Shimoyama M. Efficacy and safety of sublingual fentanyl orally disintegrating tablet at doses determined by titration for the treatment of breakthrough pain in Japanese cancer patients: a multicenter, randomized, placebo-controlled, double-blind phase III trial. Int J Clin Oncol. 2015 Feb;20(1):198-206. doi: 10.1007/s10147-014-0697-z. Epub 2014 May 20.
Other Identifiers
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2246-004
Identifier Type: -
Identifier Source: org_study_id
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